Kornimate/medical-research-clean huggingface dataset:
phase 3 clinical trial with dapagliflozin in chronic kidney disease in adolescents and young adult patients

Conditions: Chronic Kidney Failure in Children and Young Adults

Summary: recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (sglt2i) additive to angiotensin-converting-enzyme inhibitors (aceis) in adult patients with diabetic and non-diabetic chronic kidney disease (ckd). these trials included no children. the hypothesis of double pro-tect alport is to demonstrate superiority of the sglt2i dapagliflozin in preventing progression of the chronic kidney disease alport syndrome in children and young adults at early stages of disease. preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (eskf) and improved quality of life. if successful, double pro-tect alport will change the treatment recommendations for children with ckd, who have a very high unmet medical need.


Eligibility criteria:
key inclusion criteria: early stages of ckd with established diagnosis of alport syndrome at visit 1 (screening) * adolescents ≥ 10 to \< 18 years with albuminuria (uacr ≥ 300mg/g creatinine) and * egfr ≥ 30 ml/min/1.73 m2 or * adults ≥ 18 to \< 40 years with albuminuria (uacr ≥ 500mg/g creatinine) and * egfr ≥ 60 ml/min/1.73 m2 1. molecular-genetic diagnosis or diagnosis established by kidney biopsy 2. stable ras blockade as background therapy. 3. signed and dated written informed consent. key exclusion criteria: 1. medical history that might limit the individual's ability to take trial treatments. 2. treatment with any sglt2 inhibitor or within 4 weeks prior to visit 1. 3. egfr\<60 ml/min/1.73 m2 (ckd-epi) or requiring dialysis or after kidney-transplantation 4. uncontrolled arterial hypertension (blood pressure above 145/95 mmhg). 5. known hypersensitivity or allergy to the investigational products. 6. any previous or current alcohol or drug abuse. 7. participation in another trial with an investigational drug ongoing. 8. women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.

Keywords: chronic kidney disease in children pediatric population nephroprotective therapy in children alport syndrome type iv collagen disease
the relationship of acwr and fms with injury risk in adolescent players

Conditions: Injury;Sports

Summary: in this study, we examine how acute to chronic workload ratio and functional movement screen scores relate to injury risk in teenage athletes who play team sports.

at least 60 volunteer athletes who have played team sport for at least 1 year, have not been away from the field for more than 2 weeks, 15 years and older are planned to include this study. all participating athletes in this study will sign an informed consent form then their demographic information will be recorded. the injury risk of athletes will be evaluated by functional movement screen. the functional movement screen is a test battery consisting of 7 tests. these tests are deep squat, hurdle step, in-line lunge, active straight-leg raise, trunk stability push-up, rotary stability and shoulder mobility. to calculate the acute-chronic workload, internal workloads during training and/or matches will be added up over a period of 8 weeks. as part of the study, health professionals on the team will provide injury information for the athletes. sports injuries will be classified based on the type of injury (contact or non-contact) and the area of the body affected. the severity of the injury will be determined as follows: minimal (1-3 days of missed sports activity), mild (4-7 days of missed sports activity), moderate (1-4 weeks of missed sports activity), and severe (4 or more weeks of missed sports activity).

Eligibility criteria:
inclusion criteria: * be over 16 years old, * participating in a team sport for at least one year, * the players who have not stayed away from their sport for more than two weeks, exclusion criteria: * any history of orthopedic or neurological injury or pain that may interfere with normal training or competition during assessment, * structural deformities such as scoliosis and leg length inequality, * their level of activity differs from other athletes in the same sport will be excluded from the study.
combined saphenous nerve and ipack blocks versus infiltration analgesia after anterior cruciate ligament reconstruction

Conditions: Postoperative Pain; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture

Summary: a lot of patient have posterior knee pain after acl reconstruction despite saphenous nerve block. recently a new block has been described, know as ipack block (interspace between the popliteal artery and the capsule of the posterior knee). the objective of this randomized controlled double-blinded trial is to assess whether a combined saphenous nerve block with ipack block is more effective for the postoperative pain than a local infiltration analgesia.

the saphenous nerve and the ipack will be performed after general anaesthesia induction and before the surgery under ultrasound-guidance. the local infiltration analgesia will be performed by the surgeon during the surgery.

Eligibility criteria:
inclusion criteria: * statut asa i-iii. * patient scheduled for anterior crutiate ligament reconstruction under general anesthesia. exclusion criteria: * pregnancy. * contraindication to local anesthesia. * patient with chronic pain, opioid consumption or alcohol consumption. * patient with coagulation trouble, hepatic dysfunction or renal dysfunction. * patient with diabetic or femoral neuropathy.
treatment of female stress urinary incontinence: study comparing two suburethral slings, retropubic approach (tvt) and trans-obturator (tvt-o) approach

Conditions: Urinary Incontinence, Stress

Summary: the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: tvt and tvt-o.

urinary stress incontinence (usi) is a frequent pathology in women. surgical treatment is required in 30 to 50% of women presenting with usi. several surgical techniques are currently available. at the present time, the placement of suburethral slings is one of the most efficient techniques. furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications. currently, two approaches are available for the placement of a suburethral sling: retropubic approach (tvt) and trans-obturator approach (tvt-o). the efficacy of these two approaches seem equivalents. however, the morbidity related to these two techniques is probably different. in retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. on the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain. thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: tvt and tvt-o.

Eligibility criteria:
inclusion criteria: * woman over 18 years old * clinical diagnosis of stress urinary incontinence requiring surgical management * must be able to read and sign the consent exclusion criteria: * pregnancy * anti-coagulant treatment * isolated overactive bladder syndrome * genital prolapse requiring surgical treatment * concomitant hysterectomy

Keywords: urinary incontinence stress incontinence urethra gynaecologic surgical procedures suburethral sling
prospective evaluation of frailty in patients with head and neck tumors before curative intended therapy

Conditions: Head and Neck Cancers

Summary: in a prospective study the fragility of patients with head and neck tumors before the start of curative therapy will be assessed. primary objective: fragility is assessed using the g8 questionnaire. secondary objectives include the assessment of quality of life and financial burden (eortc-qlq c30+ h\&n43), swallowing function, cardiopulmonary resilience (6-minute walk test) and the patient's wishes regarding a prehabilitation program. epidemiological and disease-related data is also collected.

in this prospective study patients with a tumor of the head and neck region, that are planned for surgery or radiotherapy (chemotherapy) will be included. the probability of developing therapy-associated side effects is significantly increased if the patient is already in a limited general condition, also known as fragility, before the therapy. in addition, due to demographic change, the incidence of head and neck tumors will continue to increase, especially in patients of advanced age. due to their age, other pre-existing conditions and infirmity, they are at a further increased risk of therapy-related side effects in order to improve the care of patients with head and neck tumors, we must first determine how many patients are affected by fragility. in addition, we want to determine influencing factors that are associated with fragility. these include, for example, difficulty swallowing and weight loss. based on this data, we will then plan the implementation of an intervention study to establish a prehabilitation program.

Eligibility criteria:
inclusion criteria: * indication for curative therapy in the case of an initial diagnosis of head and neck tumor disease * capacity to consent * at least 18 years of age * sufficient knowledge of the german language exclusion criteria: * - lack of capacity to consent * age \<18 years * severe impairment of walking ability that makes it impossible to perform the 6mwt safely contraindications for performing a 6mwt: absolute contraindications\* for the procedure are * unstable angina pectoris * myocardial infarction in the past month. relative contraindications are * a resting heart rate \> 120/min * systolic blood pressure \> 180 mmhg * a diastolic blood pressure \> 100 mmhg.

Keywords: head and neck cancer frailty geriatric assessment radiation maxillo-facial surgery
anti-craving efficacy of right and left prefrontal high frequency repetitive transcranial magnetic stimulation (rtms) in alcohol dependence

Conditions: Alcohol Dependence

Summary: null hypothesis: there will be no significant difference in the change in craving parameters between right and left prefrontal high frequency rtms in patients with alcohol dependence.

the patients clinically diagnosed as alcohol dependence syndrome (f 10.24) according to icd-10 dcr, fulfilling the inclusion and exclusion criteria will be taken up for the study. a detailed physical examination will be done to rule out any major medical or neurological disease. written informed consent will be taken after explaining the objectives and procedure of the study in detail. to ensure that the patients selected are right handed, handedness preference schedule will be applied. socio-demographic data will be collected. baseline sadq-c and ciwa-ar will be administered to determine the severity of alcohol dependence and the intensity of withdrawal symptoms respectively. when the ciwa-ar score becomes ≤ 10, then they will be taken up for rtms application. for these patients baseline acq-now will be administered to measure the baseline craving. patients will be randomly allocated into two groups using randomization table. the first group will receive active rtms of the right pre-frontal cortex; the second group will be administered active rtms of the left pre-frontal cortex. each patient will receive rtms sessions 5 days a week for 2 weeks. acq-now score will again be documented in both the groups after the last rtms session to observe the changes in craving parameters. the rating will be done by one of the authors who will be blind to the nature of rtms stimulation being administered to the patients. the motor threshold (mt) for the left abductor pollicis brevis will be determined by a figure of 8 shaped coil, using the rossini-rothwell method. mt will be defined as the lowest intensity, which produces 5 motor evoked potential (mep) responses of at least 50 µv in 10 trials. the prefrontal cortex rtms stimulation site will be determined by measuring 5 cm anterior and in a parasagittal line from the point of maximum stimulation of left abductor pollicis muscle. ten active rtms treatments will be administered at 10 hz frequency, over right or left prefrontal cortex at 110% of mt for duration of 5 seconds and 20 trains per session, with the coil-angled tangentially to the head.

Eligibility criteria:
inclusion criteria: 1. diagnosis of alcohol dependence syndrome according to icd-10 dcr, 2. male patients aged between 18-60 years, 3. patients with ciwa-ar scores ≤10, 4. right handed, normotensive patients, 5. patients giving written informed consent. exclusion criteria: 1. comorbid psychiatric, major medical or neurological disorders, 2. history of withdrawal seizures, delirium tremens or significant head injury, 3. subjects with pacemaker or metal in any part of the body excluding the mouth.

Keywords: alcohol dependence craving rtms dorsolateral prefrontal cortex
the effect of concentrated pomegranate juice consumption on lipid profile and inflammatory factors in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. forty patients aged between 25-60 years old from both sexes are recruited. patients consume 50gr/day concentrated pomegranate juice for 4 weeks. anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. fasting blood sugar, lipid profile, tnf- a, il-6,hs -crp and adiponectin levels are measured. ldl are calculated by formula. the participants are asked not to change their regular diet, medicine and activity during the study.


Eligibility criteria:
inclusion criteria: * male or female 25 to 60 years old * having type 2 diabetes for at least 6 month exclusion criteria: * pregnancy * lactation * cardiac disease * hepatic disease * respiratory disease * chronic renal diseases * acute or chronic inflammation * retinopathy * intake of antioxidant supplement * insulin therapy * sensitivity to concentrated pomegranate juice * change oral drug for controlling blood glucose

Keywords: type 2 diabetes pomegranate inflammation lipid profiles
urology san antonio mri/microus comparison

Conditions: Prostate Cancer

Summary: this study compares micro-ultrasound image targeted prostate biopsy with multi-parametric mri targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

the investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-us), and multi-parametric mri (mpmri). these modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. while mpmri is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the mri gantry. instead, targets identified on mpmri are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. for this investigation, the biopsy procedure will be guided by transrectal micro-us (current standard of care at urology san antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.

Eligibility criteria:
inclusion criteria: 1. men presenting for prostate biopsy due to clinical suspicion of prostate cancer 2. 40-75 years old 3. available mpmri images and report, performed according to the pi-rads v2 standard exclusion criteria: 1. men with anorectal abnormalities preventing trus-guided prostate biopsy 2. men who are unable to provide their own informed consent 3. prostate volume on mri \> 100cc

Keywords: multiparametric mri micro-ultrasound prostate biopsy
systematic study of parameters of chronic kidney disease mineral and bone disorder (ckd-mbd)

Conditions: Renal Osteodystrophy

Summary: bone and mineral disease is a key problem in patients with kidney disease. the available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of the underlying bone pathology. the aim of this study is to use bone histology, novel bone markers and bone imaging results to establish a reliable decision model (diagnostic tool) that can be used to guide the individual therapy.

bone and mineral disease is a key problem in patients with kidney disease. the available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of the underlying bone pathology. in this study bone histology parameters including results of tetracycline labeling will be compared to non-invasive parameters of bone metabolism (e.g. sclerostin, calciprotein particles) and bone structure obtained by imaging (e.g. bone density). the aim of the study is to establish a reliable decision model (diagnostic tool) with these non-invasive parameters that can be used to guide the individual therapy. the decision model will be based on single calculations of the area under the curve for each parameter, including determination of the optimal cutpoint, sensitivity and specificity. these results will be integrated in a multivariate logistic regression analysis. the resulting model will enable to calculate the individual probability of the underlying bone diagnosis as a single value (without a specific dimension).

Eligibility criteria:
inclusion criteria: * patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings exclusion criteria: * known malignant bone or bone marrow disease

Keywords: bone biopsy; bone density
levobupivacaine during cholecystectomy

Conditions: Cholelithiasis; Pain

Summary: the purpose of this study is to determine the effects of intraperitoneal administration of levobupivacaine on pain after laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * cholelithiasis * chronic cholecystitis exclusion criteria: * hypersensitivity to local anesthetics * acute cholecystitis * morbid obesity

Keywords: laparoscopic cholecystectomy
effect of antenatal iron-contained multiple micronutrient supplementation, cesarean delivery, and cdmr on child health

Conditions: Overweight/Obesity; Anemia; Mental Development

Summary: the follow-up study was based on our previous nutritional intervention trial entitled "impact of prenatal vitamin/mineral supplements on perinatal mortality (nct00133744)". we followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). we selected a sub-sample of infants to assess their iq, emotional and behavioral problem, and language development status. the outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, iq, emotional and behavioral disorder, language developmental status, and disease history. other interesting exposure includes breast feeding, passive smoking, et al. we hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. we also hypothesize that cesarean delivery including cdmr has an impact on offspring's these outcomes.

the follow-up study was based on our previous nutritional intervention trial entitled "impact of prenatal vitamin/mineral supplements on perinatal mortality (nct00133744)". we followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). we selected 1200 \ 30 months children to measure their emotional and behavioral problem with cbcl scale. the exposure groups include intrauterine nutritional exposure and cesarean delivery exposure as well as cdmr. the outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, iq, emotional and behavioral disorder, language developmental status, and disease history. other interesting exposure includes breast feeding, passive smoking, et al. we hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. we also hypothesize that cesarean delivery including cdmr has an impact on offspring's these outcomes.

Eligibility criteria:
inclusion criteria: * all livebirths exclusion criteria: * died * moved out * refused to participate * being incapable of participation
additional manual therapy over inspiratory muscle training in copd

Conditions: Chronic Obstructive Pulmonary Disease Severe; Muscle Weakness

Summary: the benefits of inspiratory muscle training(imt) in patients with chronic obstructive pulmonary disease(copd) were reported.but in severe copd patients, benefit from imt may be limited.there is need for further research in new and complementary modalities to improve imt efficiency in severe copd patients.manual therapy(mt) additional over imt may be such a new approach that has not yet been investigated in copd. aims: to investigate effects of mt additional over imt on functional capacity,respiratory muscle strength,pulmonary function,dyspnea, fatigue and quality of life in severe copd patients. methods: it was a prospective single-blind randomized trial. 40 patients with copd in global initiative for chronic obstructive lung disease(gold) stage iii-iv were included. patients were randomly assigned to receive either mt additional over imt at 40% of maximal inspiratory pressure(mip)(n= 20) or only imt(n= 20) for 12 weeks. mt group received mt during 12 weeks for 40 minutes additional to imt. pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, functional capacity using six minute walk test, dyspnea using modified medical research council(mmrc) dyspnea scale, fatigue using fatigue severity scale and quality of life using st. george's respiratory questionnaire(sgrq) were evaluated.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic obstructive pulmonary disease * being clinically stable * having fev1/fvc ratio of ≤ 50% of the predicted value after bronchodilator drugs. exclusion criteria: * having an acute bronchitis, * having a pneumonia, * having an exacerbation of copd, * having thoracic spinal scoliosis, * having substantial chest wall deformity, or acute rib or vertebral fracture. * unable to perform the pulmonary function test because of cognitive or physical impairments.

Keywords: copd manual therapy inspiratory muscle therapy